All posts by BIadmin

Capsular Contracture


The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the implant to harden and become very painful. It can also change the shape of the breast, making it look abnormal, as shown in the photo below. The photo below is of a breast augmentation patient, but capsular contracture is even more common and often more extreme among reconstruction patients.

Baker Grade IV capsular contracture. Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

To fix capsular contracture, doctors used to perform a “closed capsulotomy.” This painful procedure involves squeezing the breast very hard to break the scar tissue capsule. This procedure should never be done. Most plastic surgeons do not perform this procedure anymore, but some do. The squeezing can break the implant and the capsule. Closed capsulotomies are not effective, and capsular contracture often comes back.

There are different grades of capsular contracture (Baker I, Baker II, Baker III, and Baker IV). They are graded based on the severity of symptoms:

Baker Grading System for Capsular Contracture

Baker I Breast is soft
Baker II Breast is slightly firm
Baker III Breast is firm and possibly misshapen and uncomfortable
Baker IV Breast is hard, painful, and misshapen

Health insurance companies that will pay for breast implant removal usually cover removal when there is severe capsular contracture (Baker III and Baker IV). This is because severe, painful capsular contracture interferes with mammography (breast cancer screening). It can also interfere with daily activities, such as reaching above your head.

Capsular contracture does not usually get better by itself. If your breasts become very painful or hard, you will need surgery. Your surgeon would need to remove the scar tissue capsule and the implant. If you have any breast tissue, it might need to be removed during the surgery because it is attached to the scar tissue.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Autoimmune Symptoms


Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1

Since many women reported problems with autoimmune or connective tissue disorder symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:2

Safety and effectiveness have not been established in patients with the following:

  • Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease.4 In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.5

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.         

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more research was needed to determine if breast implants caused specific symptoms or diseases.6

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone. A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.

Treatments and Alternatives

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)


What is BIA-ALCL?

Anaplastic Large Cell Lymphoma (ALCL) is a rare form of cancer of the immune system. Experts now agree that women with breast implants are more likely to develop ALCL1. Since it will develop in the breast area, it is called Breast Implant Associated-ALCL (BIA-ALCL). Usually, this cancer develops in the scar tissue (capsule) that forms around a breast implant2. Sometimes this cancer can be found in the lymph nodes. If it’s not treated quickly, it can be fatal.

How can breast implants cause cancer? Why didn’t my doctor mention it?

Scientists are trying to figure out why ALCL forms near breast implants. Many experts believe that cancer may develop in response to chronic inflammation caused by bacteria3. Most cases of BIA-ALCL have been reported in women with textured implants, which provide a better surface for bacteria to grow.

The apparent link between ALCL and breast implants was published by cancer experts in 2009.  It wasn’t until 2011 that the Food and Drug Administration (FDA) warned the public, and it wasn’t until 2013 that cancer researchers published an article in a medical journal stating that breast implants could cause ALCL.  By 2016, BIA-ALCL was widely recognized by cancer experts, but not all oncologists are aware of it.  Many breast cancer survivors are upset to realize that their “cautious” choice to have a mastectomy with implants rather than a lumpectomy puts them at risk of developing ALCL.

Is BIA-ALCL really rare?

The U.S. Food and Drug Administration (FDA) says that it has received 359 reports of ALCL, including 9 deaths, in women with breast implants. They say that since millions of women have breast implants, BIA-ALCL must be very rare. However, the Australian version of the FDA (called the Therapeutic Goods Administration) estimates that between 1 in 1,000 and 1 in 10,000 women with breast implants will develop ALCL4.

More than 300,000 women get breast implant surgery every year. If the Australian estimates are correct, about 30-300 of those women will develop ALCL every year. However, many experts believe that ALCL is underreported and therefore the chance of developing ALCL from breast implants is likely higher than the current estimates. Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.

How will I know if I have BIA-ALCL?

All women with breast implants should be seeing a doctor regularly to check for any problems. If you experience redness or swelling near your implants you should see a doctor immediately. A swollen breast is usually an infection, but the fluid around your implants should be tested for ALCL as well.

Although a swollen breast is the most common symptom of BIA-ALCL, not all women with BIA-ALCL have noticeable swelling. Some women with BIA-ALCL reported feeling a lump near their implant or capsular contracture. If you find a lump, see your doctor immediately to check for breast cancer or ALCL. If you have capsular contracture, keep in mind that it could be a sign of BIA-ALCL, even though it probably isn’t.

How can I prevent BIA-ALCL?

You can’t prevent ALCL if you have breast implants. However, you can watch out for warning signs mentioned and have regular checkups with a doctor who knows about BIA-ALCL and other risks associated with breast implants.

What is the treatment for BIA-ALCL?

ALCL is treated by removing the implant and all of the surrounding scar tissue. This procedure is called a total capsulectomy, or an “en bloc” removal. This is done to make sure any cancer cells in the tissue are removed.

If any of your lymph nodes are found to have ALCL, they will also be removed.

If the cancer is found later and has spread, you may need to be treated with chemotherapy or radiation therapy.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. FDA, Center for Devices and Radiological Health. (2017). Breast Implants – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
  2.  Swerdlow, S. H., Campo, E., Pileri, S. A., Harris, N. L., Stein, H., Siebert, R., et al. (2016). The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, 127, 2375-2390. doi:10.1182/blood-2016-01-643569
  3.  Kadin, M. E., Deva, A., Xu, H., Morgan, J., Khare, P., Macleod, R. A., Epstein, A. L., et al. (2016). Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic Surgery Journal, 36(7), 773-781. doi:10.1093/asj/sjw023
  4. Therapeutic Goods Administration. (2017). Breast implants and anaplastic large cell lymphoma. Retrieved from https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

Private Insurance Help for Augmentation Patients


Follow these steps to try to get insurance coverage for your breast implant removal:

1) Find out whether your insurance company considers removal “medically necessary”

Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree.

Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures.  However, many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies usually won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms.

How do I know whether my insurance company will cover the cost of removal?

To find out if your insurance company is likely to cover removal, you will need to look at your specific policy language. You can usually find this language in a document called “Evidence of Coverage” (EOC). It is a document (and is often quite lengthy!) that describes in detail the healthcare benefits covered by your health plan, including procedures that your insurance company will and will not cover.

You can access an electronic copy of your EOC through your online account on your insurance company’s website. You can also call the member services number on the back of your insurance card and ask an insurance representative for a copy of this document.  

What do I look for?

Once you have your policy, look for language about breast implant removal.  If you don’t see any language about breast implant removal, search for language on cosmetic surgery. If you cannot find any specific language about breast implant removal, you should also look to see what your insurance company’s definition of “medically necessary” is. It is also important to check whether your insurance plan requires pre-authorization for any surgeries.

If you’re using an electronic copy, you don’t need to read the entire document. You can easily find terms using the “Control+F” keys on your keyboard. That will provide a “search box” that will search for any words you enter. Just enter the word “implant” or “cosmetic” or “silicone” in the search box. If you are unable to find what you need in the lengthy document, call your member services line and ask for assistance to locate the correct pages.

2) File for pre-authorization

Most insurance companies will require that you get pre-authorization (also called prior approval or pre-certification) before the surgery. This means your insurance company reviews your relevant information and determines whether surgery is medically necessary. Then, the insurance company will let you know if it is likely to cover your surgery. However, that pre-authorization isn’t a promise that your surgery will be covered.

The easiest way to get pre-authorization is to have your plastic surgeon sign and submit a letter that lists your symptoms and explains why removal is medically necessary based on your insurance policy language. (Usually one or more of health problems listed on the bullets earlier in this article). Your surgeon should also enclose any medical documentation that provides proof of your symptoms. 

It is best if your plastic surgeon signs this letter to send with your insurance claim. However, if your surgeon is unwilling to sign the letter, another doctor involved with your care, such as your primary care provider, can sign. You can find templates for these letters here. If your doctor agrees to sign the letter, but won’t submit it to your insurance company, you will need to submit the letter before your surgery to ensure you receive pre-authorization.

NOTE: If you don’t get pre-authorization when it was required, the insurance company isn’t required to cover the surgery, even if it considers the procedure to be medically necessary.

3) After your surgery: filing a claim

If your surgeon is in your insurance company network, he/she should file a claim on your behalf. If not, you will need to file the reimbursement claim with your insurance company. If you didn’t seek pre-authorization before your surgery, you can still file a reimbursement claim.  You will need to submit your pre- and post-operative reports, along with a letter from the surgeon stating that the procedure was medically necessary. However, as we stated above, if your insurance company requires pre-authorization, it is unlikely that they will reimburse you for your surgery, even if your surgery was medically necessary. Therefore, we suggest that you file a pre-authorization claim to improve your chances of getting insurance coverage.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Autoimmune Symptoms


Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.7

Since many women reported problems with autoimmune or connective tissue disorder symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:8

Safety and effectiveness have not been established in patients with the following:

  • Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.9

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease.10 In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.11

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.         

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more research was needed to determine if breast implants caused specific symptoms or diseases.12

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone. A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.

Treatments and Alternatives

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Big Pharma Greets Hundreds of Ex-Federal Workers at the ‘Revolving Door’

Sydney Lupkin, Kaiser Health News: January 25, 2018

Alex Azar’s job hop from drugmaker Eli Lilly to the Trump administration reflects ever-deepening ties between the pharmaceutical industry and the federal government.

A Kaiser Health News analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services.

Azar was confirmed Wednesday as  HHS secretary, joining other former drug industry alumni in top positions.

Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by Legistorm, a nonpartisan congressional research company. On the flip side, the analysis showed, more than a dozen former drug industry employees now have jobs on Capitol Hill — often on committees that handle health care policy.

“Who do they really work for?” said Jock Friedly, Legistorm’s president and founder, who called that quantity “substantial.” “Are they working for the person who is paying their bills at that moment or are they essentially working on behalf of the interests who have funded them in the past and may fund them in the future?”

In many cases, former congressional staffers who now work for drug companies return to the Hill to lobby former co-workers or employees. The deep ties raise concerns that pharmaceutical companies could wield undue influence over drug-related legislation or government policy.

“You’ll take the call because you’ve got a friendly relationship,” said Diana Zuckerman, president of the nonprofit National Center for Health Research and a former congressional staffer. “You’ll take the call because these people are going to help you in your future career [and] get you a job making three times as much.”

A 2012 Sunlight Foundation investigation found that, on average, a chief of staff on the Hill could increase his or her salary 40 percent by moving to the private sector.

Experts say the cozy relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt.

When John Stone left the House Energy and Commerce Committee last fall to join lobbying firm BGR, he told Politico that he had consulted with two lobbyists at BGR “for advice on basically everything that came across my desk.”

KHN’s review of Legistorm data indicates that one of the lobbyists, BGR’s Ryan Long, overlapped with Stone on the House panel. Brent Del Monte preceded them both on the committee and then spent 10 years at the Biotechnology Innovation Organization (BIO), a trade group for the biologic drug industry, before joining BGR in 2015. BGR’s clients include PhRMA, Celgene and other pharmaceutical firms.

Like Stone, Long and Del Monte, many ex-Hill staffers working in some way for the pharmaceutical industry came from key committees, including the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Energy and Commerce Committee, which in 2016 shepherded the 21st Century Cures Act into law. The law faced criticism from watchdogs who feared it would make drug approval cheaper and easier but could lead to unsafe approvals.

Tim LaPira, a James Madison University associate professor who co-authored a book about the revolving door published in June, said the practice of leaving government service to lobby for industry isn’t as corrupt as it seems. Rather, as congressional staffs have shrunk over time, they’ve been forced to essentially outsource expertise to lobbyists, he said.

“Don’t tell the private sector to stop doing it. Tell Congress to stop relying on the private sector so much,” LaPira said, adding that Congress spends just 0.5 percent of the discretionary budget on itself.

The number of congressional employees declined by more than 7,000 people — about 27 percent — from 1979 to 2015, according to data compiled by the Brookings Institution, a nonprofit research group.

While there’s a fear that lobbyists are slipping industry-friendly language into legislation, LaPira explained, more often they’re monitoring what’s happening inside government.

The reverse-revolving door, in which former pharmaceutical employees enter public service, is not as clearly understood. Neither is the flow of serial revolvers, who go from industry to government and back.

Some of those Hill staffers, according to financial disclosures, maintain drug industry pensions and stock, Kaiser Health News found. They are not required to divest and are required to disclose those connections only if they hold key positions.

Reverse revolvers may not realize they’re doing Big Pharma’s bidding, Friedly said, but they’ve been so exposed to the industry’s point of view that their implicit biases may seep into their legislative work.

The revolving door operates beyond the Hill, however, LaPira said

In addition to Azar, several former drug industry officials have landed key jobs in Trump’s Cabinet and administration, including Food and Drug Administration Commissioner Scott Gottlieb, a former venture capitalist with deep ties to the pharmaceutical industry.

Gottlieb disclosed serving on boards of several pharmaceutical companies, including GlaxoSmithKline and Daiichi Sankyo, prior to returning to government for his third trip through the revolving door.

KHN also reviewed the résumés of more than 100 HHS appointees, obtained via a Freedom of Information Act request by American Oversight, a nonprofit founded to hold government officials accountable. Although only a handful of recent appointees were employed directly by drug companies, more than a dozen had worked as lobbyists, consultants and lawyers on behalf of pharmaceutical firms.

The high-level HHS appointees include: Keagan Lenihan, a former lobbyist for drug distributor McKesson who now serves as senior counselor to the secretary at HHS; former PhRMA lobbyist John O’Brien, now deputy assistant secretary of health policy for the agency’s Planning and Evaluation arm; and former Bristol-Myers Squibb lobbyist Mary-Sumpter Lapinski, an attorney in the HHS secretary’s office.

Sen. Elizabeth Warren expressed concerns about the revolving door during Azar’s confirmation hearing before the HELP committee in November. Not long after telling Azar that his “résumé reads like a how-to manual for profiting from government service,” she asked him whether drug industry CEOs should be held accountable when the companies they run break the law. He did not answer yes or no.

His reply: “I’m satisfied with our discussion.”

METHODOLOGY

Kaiser Health News obtained revolving-door and lobbying disclosure data from Legistorm, a for-profit, nonpartisan congressional research firm based in Washington, D.C.

The revolving-door data include congressional staffers’ jobs on and off Capitol Hill. It is current through August 2017 and dates to 2001. For lobbyists who did not directly work for pharmaceutical firms but worked for lobbying firms on behalf of pharmaceutical companies and their trade groups, Kaiser Health News used lobbying disclosure data to identify individuals registered to lobby on behalf of these clients. Reporters then tracked down these lobbyists in Legistorm’s revolving door data and checked them by hand.

The HHS appointee résumés obtained by American Oversight covered individuals appointed from Jan. 20 to July 12, 2017.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Read the original article here.

The FDA’s Regulation of Silicone Breast Implants

U.S. Congress, Report of the Subcommittee of Human Resources and Intergovernmental Relations of the House Committee on Government Operations, 1993

The FDA’S Regulation of Silicone Breast Implants

I. Introduction

Under the Rules of the House of Representatives, Rule X, 2(b)(2), the Committee on Government Operations is authorized to “review and study, on a continuing basis, the operation of Government activities at all levels with a view to determining their economy and efficiency.” The committee has assigned this responsibility, as it pertains to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to the Human Resources and Intergovernmental Relations Subcommittee.

Pursuant to its authority, the subcommittee conducted an investigation of the safety and effectiveness of silicone breast implants, the regulation of those devices by the FDA, and research support by the NIH.

On December 18, 1990, the subcommittee conducted a hearing on the FDA’s regulation of silicone breast implants. The hearing included testimony from the following FDA witnesses: Walter Gundaker, Acting Director, Center for Devices and Radiological Health; Mr. Robert Sheridan, Director, Office of Device Evaluation; and Dr. Joseph Arcarese, Director, Office of Training and Assistance. Other witnesses included Dr. Nir Kossovsky, assistant professor of pathology and laboratory medicine at the University of California at Los Angeles; Dr. Frank Vasey, professor of medicine at the University of South Florida; Dr. Pierre Blais former senior scientific advisor for the Department of National Health and Welfare of Canada; Dr. Norman Anderson, former Chair of the FDA panel that reviewed the breast implant issue in 1988-90; Mr. Thomas D. Talcott, an engineer specializing in silicone implants for 20 years at Dow Corning; and Mr. Robert Rylee, vice president of Dow Corning Wright. Implant patients Sybil Goldrich, co-founder of Command Trust Network; Rosemary Locke of My Image After Breast Cancer; and Janet Van Winkle, founder of the American Silicone Implant Survivors (AS IS), also testified. Officials of three other manufacturers, Mentor, McGhan, and Surgitek, declined the subcommittee’s invitation to testify.

[…]

Read the original article here.

Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants

Linda MacDonald Glenn, Women’s Bioethics Project, April 2005

My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women’s Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in healthcare and technology.

I am a biomedical ethicist, attorney, educator, and long-time patient advocate. I spent 20 years as an attorney, a prosecutor, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman’s Bioethics Project scholar. I have no financial conflict of interest.

“Tell me what you don’t like about yourself.” This catchphrase is the opening line to the controversial TV drama “Nip/Tuck” that sums up a plastic surgeon’s attitude towards his patient. The implication is that plastic surgeon can fix what you don’t like about yourself.

And while we’re not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman’s choice; in other words, “Let us help you feel better about yourself.” But, as I will follow up and explain, the FDA’s summary of the manufacturer’s own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today. Issues of long-term safety and truly informed consent are the primary concerns.

In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up with a slogan, “Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.

The slogan “The right to choose” implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.

Mentor’s own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.

To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.

The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long-term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.

Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn’t even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long-term safety are established.

Thank you for your thoughtful consideration in listening today.

Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies

Marcy Gross, State of Maryland Women’s Health Promotion Council, April 2005.

I am Marcy Gross, a consultant who specializes in women’s health issues. I am a member of the State of Maryland Women’s Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women’s Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six-year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long-term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short-term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third — and this is a change from the past — the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don’t know when.

I would assert that if this were an NIH-funded research study, it’s unlikely it would go forward.


Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor.